Michelle Vuolo is the Head of Quality at Tulip Interfaces, Inc., a platform developer that allows manufacturers of many industries to build digital content to manage their operations. Before joining Tulip, Michelle spent over 24 years in the biopharmaceutical and medical devices industries in quality control laboratories, engineering technical support, quality assurance management, and computerized systems compliance. Michelle has a strong understanding of the needs of the life sciences industry and is motivated to evolve stagnant ways of meeting compliance requirements, especially as it relates to the 4.0 world. She joined ISPE in 2008.
Co-Lead Validation 4.0 Working Group
Member of the ISPE Pharma 4.0 Steering Committee
A fundamental GMP requirement is that processes, systems, and methods used to produce medicines and treatments are validated, meaning their fitness for a purpose is demonstrated. If Industry 4.0 is to succeed in the pharma space as
The Life Sciences industries adhere to strict documentation practices to prove quality and compliance. We’re all familiar with the truism “If it isn’t written down, it didn’t happen.”